Recalls / —

—#25914

Product

Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter

510(k) numbers

K011342, K962988

Affected lot / code info

In the LH 700 series, all serial numbers up to AE1088.  In the GENS series, all instruments.

Why it was recalled

Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.

Root cause (FDA determination)

Other

Action the firm took

Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2002-12-10

Posted by FDA

2003-02-25

Terminated

2004-04-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25914. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.